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COMPLETED
NCT03348891
NA

TNF in Melanoma Patients Treated With Immunotherapy

Sponsor: Institut Claudius Regaud

View on ClinicalTrials.gov

Summary

This trial is a translational proof-of-concept, open-label, prospective cohort study of 60 patients aiming to identify the clinical markers and/or biomarkers associated with therapeutic response to immune checkpoints inhibitors, in patients with advanced melanoma. The study will be conducted on a population of patients treated with ICI in the context of routine care, separated in two subgroups: * Subgroup 1: patients treated with anti-PD-1 alone (nivolumab or pembrolizumab) * Subgroup 2: patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab) For each included patient, blood samples will be collected during baseline visit and during treatment period (at Week 6 Day 1 and Week 12 Day 1). If feasible, tumor biopsy (of primary tumor or metastasis) will be performed during baseline and on Week 12 Day 1 visit (predose). If tumor biopsy is not feasible, available archived tumor specimen (frozen or FFPE block) may be collected for the study. All included patients will be followed-up for tumor status and/or survival status every 3 months until a maximum duration of 1 year from the first study dose.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2018-09-05

Completion Date

2021-11-22

Last Updated

2026-04-14

Healthy Volunteers

No

Conditions

Interventions

OTHER

Tumor biopsy specimens and blood samples

Tumor biopsy specimens (if feasible) and blood samples will be collected at Baseline, Week 6 Day 1 (blood sample only) and Week 12 Day 1.

Locations (3)

CHRU Claude HURIEZ

Lille, France

CHU Montpellier Saint-Eloi

Montpellier, France

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France